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Sheraton Silver Spring

09 oct 2018 7:30 a.m. - 10 oct 2018 5:15 p.m.

8777 Georgia Ave, Silver Spring, MD 20910

Complex Drug-Device Generic Combination Products Meeting

Panel Discussion

Speaker(s)

Markham  Luke, MD, PhD

Moderator

Markham Luke, MD, PhD

FDA, United States

Director for Therapeutic Performance, Office of Generic Drugs, CDER

Charles  DiLiberti, MS

Panelists

Charles DiLiberti, MS

Montclair Bioequivalence Services, LLC, United States

President

Xiaohui (Jeff)  Jiang

Panelists

Xiaohui (Jeff) Jiang

FDA, United States

Division Deputy Director, Division of Therapeutic Performance, Office of Generic

Darby  Kozak, PhD

Panelists

Darby Kozak, PhD

FDA, United States

Lead for Complex Drug Substances and Dosage Forms, OGD, CDER

Andrew A. LeBoeuf, JD, MS

Panelists

Andrew A. LeBoeuf, JD, MS

FDA, United States

Associate Director Regulatory Policy, ONDP, OND, CDER

Sam G. Raney, PhD, MS

Panelists

Sam G. Raney, PhD, MS

FDA, United States

Associate Director for Science, ORS, Office of Generic Drugs, CDER

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